Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
WO 2021/243200
PCT/US2021/034844
WEARABLE DIALYSIS SYSTEM WITH ULTRAFILTRATE MODULE
CLAIM OF PRIORITY
100011 This patent application claims the benefit of priority
to U.S. Application Serial
No. 63/032,272, filed May 29, 2020, which is incorporated by reference herein
in its entirety.
BACKGROUND
[0002j Hemodialysis can be a renal replacement therapy used by
patients who have
end stage renal disease (ESRD). These patients can no longer rely upon their
kidneys to
provide desired removal of waste from the blood. Hemodialy-sis can involve
extracorporeal
removal of toxins from a patient's blood using a dialyzer, where the toxins
diffuse across a
semipermeable membrane in the dialyzer to a dialysate solution due to a
concentration
gradient across the membrane.
SUMMARY OF THE DISCLOSURE
100031 Additional aspects and advantages of the present
disclosure will become
readily apparent to those skilled in this art from the following detailed
description, wherein
only some examples of the present disclosure are shown and described, simply
by way of
illustration of the several modes or best mode contemplated for carrying out
the present
disclosure. As will be realized, the present disclosure is capable of other
and different
examples, and its several details are capable of modifications in various
obvious respects, all
without departing from the disclosure. Accordingly, the drawings and
description are to be
regarded as illustrative in nature, and not as restrictive.
100041 In an example, a system for hemodialysis can include a
first dialysis module
and an auxiliary module detachably connectable to the first dialysis module.
The first dialysis
module can include a dialyzer, a blood circuit configured to receive blood
from a patient,
circulate the blood through the dialyzer, and return cleaned blood to the
patient, a dialysate
circuit configured to circulate dialysate through the dialyzer an.d remove
impurities from the
blood and a first sorbent for removing toxins from the blood. The auxiliary
module can
include a pump connectable to the dialyzer for pumping the dialysate through
the dialysate
circuit and a filter configured to remove fluid from the system, the filter
fluidly coupled to the
pump and the dialysate circuit.
1
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
100051 In an example, a method of hemodialysis can include
continuously removing
toxins from blood with a portable dialysis module situated on the patient's
body and
selectively removing excess fluid from. the portable dialysis module by
connecting the
portable dialysis module to a detachable auxiliary module comprising an
ultrafiltrate
collector.
BRIEF DESCRIPTION OF THE DRAWINGS
100061 In the drawings, which are not necessarily drawn to
scale, like numerals may
describe similar components in different views. Like numerals having different
letter
suffixes may represent different instances of similar components. The drawings
illustrate
generally, by way of example, but not by way of limitation, various examples
discussed in the
present document.
100071 FIG. 1 is a schematic diagram of a portable daytime
hemodialysis system with
a detachable auxiliary pump module in an example.
100081 FIG. 2 is a schematic of a stationary nighttime
hemodialysis module for use
with a daytime hemodialysis system, in an example.
100091 FIGS. 3A-3B are schematic diagrams of a portable
daytime hemodialysis
system with a detachable auxiliary pump module in an example.
100101 FIGS. 4A-4C are perspective views of a portable daytime hemodialysis
system
in an example.
100111 FIGS. 5A-5C are perspective views of a portable daytime
hemodialysis system
in an example.
100121 FIG. 6 is a flow chart depicting a method of using a
hemodialysis system in an
example.
DETAILED DESCRIPTION
100131 While some examples of the invention have been shown
and described herein.,
it will be obvious to those skilled in the art that such illustrations are
provided by way of
example only. Numerous variations, changes, and substitutions will now occur
to those
skilled in the art without departing from the invention. It should be
understood that various
alternatives to the examples of the invention described herein may be employed
in practicing
the invention.
2
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
100141 Disclosed is a system and methods of hemodialysis. The
system includes a
portable daytime module that can be comfortably worn by the patient during
normal daytime
activity. The daytime module can plug into a stationary nighttime module
having additional
sorbents, such as for removal of urea. The daytime and nighttime modules can
share a pump,
dialysate circuit, and blood circuit. The system has a detachable auxiliary
pump and
ultrafiltrate module to allow for improved portability of the daytime module.
100151 Hemodialysis, commonly called kidney dialysis or simply
dialysis, is a
process of purifying the blood of a person whose kidneys are not working
normally. This type
of dialysis achieves the extracorporeal removal of waste products such as
creatinine and urea
and free water from the blood when the kidneys are in a state of kidney
failure. Hemodialysis
can be an outpatient or inpatient therapy. Routine hemodialysis is conducted
in a dialysis
outpatient facility, either in a purpose built room in a hospital or a
dedicated, stand-alone
clinic, or at home. Less frequently hemodialysis is done at home. Dialysis
treatments in a
clinic are initiated and managed by specialized staff made up of nurses and
technicians;
dialysis treatments at home can be self-initiated and managed or done jointly
with the
assistance of a trained helper.
100161 Conventional hemodialysis has a number of
disadvantages, such as restricted
independence, as people undergoing this procedure cannot travel around because
of supplies'
availability and being tethered to a large stationary device during treatment;
requires high
water quality; a large quantity of water; and continuous source of
electricity, typically
provided by a power plug connected to an outlet; requires reliable technology
like dialysis
machines; requires care givers having more knowledge of the complicated
procedure and
equipment; requires ongoing and repetitive time to set up and clean dialysis
machines.
100171 Additionally, hemodialysis often involves fluid removal
through
tdtrafiltration, as most patients with renal failure pass little or no urine.
Side effects caused by
removing too much fluid or removing fluid too rapidly can include low blood
pressure,
fatigue, chest pains, leg-cramps, nausea and headaches. These symptoms can
occur during the
treatment and can persist post treatment; they are sometimes collectively
referred to as
"dialysis hangover" or "dialysis washout." The severity of these symptoms is
usually
proportionate to the amount and speed of fluid removal. However, the impact of
a given
amount or rate of .fluid removal can vary greatly from person to person and
day to day.
100181 Conventional hemodialysis is usually done three times
per week, for about 3-4
hours for each treatment, during which the patient's blood is drawn out
through a tube at a
3
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
rate of 200-400 mL/min. The tube is connected to a 15, 16, or 17 gauge needle
inserted in the
dialysis fistula or graft, or connected to one port of a dialysis catheter.
The blood is then
pumped through the dialyzer, and then the processed blood is pumped back into
the patient's
bloodstream. Optionally in any example, the blood can be pumped to the patient
through
another tube connected to a second needle or port. Optionally in any example,
the blood can
be pumped to the patient through a dual lumen catheter at the same location
where blood is
removed from the body, such as to allow one access point to the body to both
remove and
return blood in two separate lumens.
1001.91 During the procedure, the patient's blood pressure is
closely monitored, and if
it becomes low, or the patient develops any other signs of low blood volume
such as nausea,
the dialysis attendant can administer extra fluid through the machine. During
the treatment,
the patient's entire blood volume (about 5000 cc) circulates through the
machine every 15
minutes. During this process, the dialysis patient is exposed to a week's
worth of water for the
average person. Daily hemodialysis is typically used by those patients who do
their own
dialysis at home. It is less stressful (more gentle) but does require more
frequent access.
Daily hemodialysis is commonly done for 2 hours six days a week. The procedure
of
nocturnal hemodialysis is similar to conventional hemodialysis except it is
typically
performed three to six nights a week and between six and ten hours per session
while the
patient sleeps.
100201 Described herein are systems and methods related to a dialysis
system which
can include both a first dialysis module which performs dialysis functions
during a period
when the patient desires to be mobile, such as during the daytime, and a
second dialysis
module configured to perform dialysis functions during a period of time when
mobility is not
as important to the patient, such as during the nighttime. The system can also
include a
detachable auxiliary module for collection of ultrafiltrate and liquid
removal.
100211 The patient can alternate use of the first dialysis
modules alone, and the
second dialysis module in conjunction with the first dialysis module, such as
during a 24-
hour period. The patient can selectively attach or detach the auxiliary module
to allow for
removal of fluid at various parts of the day or attach the auxiliary module
for an extended
period of time when stationary.
[00221 The first dialysis module can be worn by the patients,
such as under their
clothes. The first dialysis module is lightweight and/or compact to facilitate
transport of the
system such that patients can maintain activities of daily life. The removal
or addition of the
4
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
auxiliary module with an tdtrafiltrate collector can allow even more patient
movement and
mobility during the day.
100231 Meanwhile, the second dialysis module connects into the
first dialysis module
to create a stationary dialysis system, configurable to provide additional
toxin removal
functions. The stationary dialysis system is stationary, for example being
configured to be
positioned on a support. This can allow a patient to be mobile during the day
while
maintaining overall desired removal of toxins.
100241 FIG. 1 is a schematic diagram of a portable daytime
first dialysis module 100
with a detachable auxiliary pump module 180. The portable daytime hemodialysis
system
("first dialysis module") 100 can be configurable to be transported by a
patient, for example
to perform toxin removal functions while a patient is mobile, such as during
the daytime. The
first dialysis module 100 can be lightweight and compact in size to provide
desired patient
mobility. For example, the first dialysis system can be of a weight less than
5 lbs., less than 4
lbs., less than 3 lbs., less than 2.5 lbs., less than 2 lbs., less than 1.5
lbs., or less than 1 lb. 'The
first dialysis module 100 can be configurable to be worn by the patient while
the patient is
going about his or her daily business without requiring tethering to external
power sources or
external components. For example, the first dialysis module 100 can be a
wearable artificial
kidney. The first dialysis module 100 can be coupled to a belt such that the
first dialysis
module 100 is worn by the patient. The first dialysis module 100 can be wom by
the patient,
but otherwise untethered.
100251 The first dialysis module 100 can include a dialyzer
110, a pump 120, a blood
circuit 130, a dialysate circuit 150, a sorbent cartridge 170, auxiliary
module 180, control unit
190, power source 192, user interface 194, and power jack .195.
100261 The dialyzer 110 can have a dialysate input 112, a
dialysate output 114, a
blood inlet 116, and a blood outlet 118. Dialysate can flow through the
dialyzer 110 in a first
direction while the blood flows through the dialyzer 110 in a counter current
flow. Counter
current flow can maximize the gradient between the dialysate circuit 150 and
the blood
circuit 130, therefore maximizing exchange across the dialyzer 110
membrane.Toxins from
the blood flow can diffuse into the dialysate across semi-porous membranes of
the dialyzer
110 as the blood and dialysate flow across opposing surfaces or the semi-
porous membranes.
In an example, blood flow can travel in a clockwise fashion through the blood
circuit 130,
while the dialysate can flow in a counterclockwise fashion through the
dialysate circuit 150.
5
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
[0027] In dialysis systems, some toxins be removed at a steady
rate over a 24-hour
period, but generally not faster. However, some toxins can be removed over
shorter periods
of time without negative consequences to the patient. There are two types of
toxins: those
bound to protein; and free toxins. Free toxins are generally considered to be
more toxic.
Examples of toxins that require removal over 24 hours include p-cresyl and
indoxyl sulfate.
These are part of a group of toxins called protein bound toxins (P-BUTS). The
free form,
which is the only toxic one, comes out in the urine, keeping its level low in
a healthy patient.
In dialysis the free fraction conies out on dialysis and the level of the free
toxin is also low,
however, as soon as the patient is on a dialysis machine, the protein bound
toxins re-
equilibrate with the free fraction, that comes up again to toxic levels. There
are about 25
known P-BUTS. The first dialysis module 100 can be configured to remove toxins
at a steady
rate over a 24-hour period.
100281 The pump 120 can have a dialysate input 122, a
dialysate output 124, a blood
inlet 126, and a blood outlet 128. The pump 120 can be a side-to-side
pulsatile pump. The
side-to-side pulsatile pump 120 can be powered by a battery, including a
rechargeable
battery, and/or by an electrical wall outlet. For example, the side-to-side
pulsatile pump 120
can be powered by a battery to enable transport of the pump 120, thereby
facilitating
transport of the dialysis system which incorporates the pump 120, such as
first dialysis
module 100. An example of such a side-to-side pump is disclosed in US Pat.
App. No.
15/890,718; the entire contents of which are incorporated herein by reference.
[0100] The side-to-side pulsatile pump 120 can be configured
to retain a blood tubing
permitting the flow of blood therethrough from the patient, and a dialysate
tubing permitting
flow therethrough of dialysate, within a pump casing. The pump can include a
compression
disc configured to provide side-to-side motion to apply a first pressure to
the blood ventricle
tubing and a second pressure to the dialysate ventricle tubing in alternate
fashion. This can
allow for alternating pumping of the blood circuit 130 and the dialysate
circuit 150. In some
cases, the pump can be driven by a motor and gear box. The pump 120 can create
a pulsatile
flow where the blood pulses are out of phase with the dialysate pulses, such
that, for example,
the peak of the blood pulse is 90 to 180 degrees out of phase with the peak of
the dialysate
flow.
101011 One or more side-to-side pulsatile pumps described
herein can be configured
to provide desired pumping volume for both blood and dialysate, while reducing
or
eliminating problems associated with known pumps. Optionally in any example,
one or more
6
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
side-to-side pulsatile pumps described herein can provide pumping volumes of
greater than
about 35 milliliter per minute (mUmin). Optionally in any example, a dialysis
system using a
side-to-side pulsatile pump can provide a flow rate of dialysate of about 100
mUmin.
100291 The blood circuit 130 can have an inlet 132, a flow
control element 134, a
saline flush 136, a blood thinner hookup 138 with pump 139, a bubble filter
140, a bubble
detector .141, a flow sensor 142, a flow control element 143, and an outlet
144. The blood
circuit can contain first portion 146 and second portion 148. The first
portion contains
undialyzed blood, the second portion contains dialyzed blood. The blood
circuit 130 can, for
example, be made of tubing or other conduit suitable for flow of blood. The
flow control
elements 134, 143, can be elements such as valves, clamps, or other elements
that allow for
turning off and on blood flow, or otherwise controlling flow rates through the
blood circuit
130.
100301 In the first portion 146 of the blood circuit 130, the
inlet 132 can be configured
for attachment to a patient. In some cases, the inlet 132 can be a blood
thinner infusion inlet,
such as for adding blood thinner to the blood flow to prevent blood clots from
forming within
the blood circuit 130 of the first dialysis module 100. In some cases, such as
shown in first
dialysis module 100, the blood thinner hookup 138 can be separate from the
inlet. Such a
hookup can be connected to a blood thinner reservoir (not shown). Example
blood thinners
can include heparin, or more specifically, low molecular weight heparins,
direct thrombin
inhibitors, danaparoid, ancrod, r-hirudin, abciximab, tirofiban and
argatroban, among others
known to those skilled in the art. Optionally in any example, a blood thinner
infusion inlet
can be positioned elsewhere on the blood circuit 130, such as after the pump
120. The
infusion of one or more blood thinners into the blood circuit .130 can be
actuated, for
example, by the pump 139.
100311 The first portion 146 can include flow of blood from the patient
that has not
yet been treated for toxins. The second portion 148 can include flow of blood
back to the
patient that has been treated for toxins. In the first portion 146, the blood
circuit 130 can
allow for flow of blood from the inlet 132 through the pump 120 to the
dialyzer 110 via blood
inlet 116, where toxins can be removed. In the second portion 148, upon
exiting the dialyzer
at blood outlet 118, blood can flow towards the outlet 144 towards the
patient. The blood
flow can run through a number of optional components which may be included in
any
example, such as the bubble filter 140 and bubble detector 141, the flow
sensor 142, or other
sensors or filters.
7
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
[00321 The bubble filter 140 and bubble detector 141 can be in
fluid communication
with the blood flow exiting the dialyzer 110 such that presence of air bubbles
within the
blood is detected and communicated to the control unit 190. The control unit
190 is
configurable to pause and/or power off the first dialysis module 100 upon
detection of air
bubbles within the blood flow.
100331 The flow sensor 142 can be in line or parallel to the
blood circuit 130, such as
in second portion 148 of the blood circuit. The flow sensor 142 can be
configured to measure
the rate at which blood is flowing through the first dialysis module 100.
Optionally in any
example, one or more flow sensors can be alternatively or additionally be on
the dialysate
circuit for measuring flow of dialysate. The flow sensor 142 can be a
mechanical flow meter,
a pressure-based flow meter, a variable area flow meter, an optical flow
meter, combinations
thereof, or other type of flow sensors.
100341 The flow sensor 142 on the blood circuit 130 can detect
the volume of blood
moving through the blood circuit over a given time period. This information
can be
communicated to the control unit 190, which is turn can monitor the flow of
blood through
the circuit, lithe blood flow is outside of a normal range, the control unit
190 can alter the
movement of the dialyzer 110 and pump 120 to change the flow of blood and/or
dialysate
through the module 100. For example, if the blood flow is too slow, it may
indicate a clot or
blockage, which may need to be addressed. Optionally in any example, a change
in flow may
trigger an alarm such as an audible, visual, tactile, or other indicia to the
user. If the blood
flow is too quick, the control unit 190 can slow the mechanism of the pump 120
to modulate
the flow of fluid in the module 100 accordingly.
100351 Optionally in any example, the first dialysis module
100 can additionally
include a pH sensor 129 tied to the control unit 190 such as to test for
ammonia in the blood
circuit. The pH sensor 129 can be, for example, positioned between the
dialyzer 110 and the
outlet 144. Since ammonia is such a strong base, the pH sensor 129 can provide
a safety
mechanism to detect when the sorbent cartridges are no longer effective for
removing
ammonia from the system. The optional pH 129 sensor can. be in fluid
communication with
the blood flow exiting the dialyzer 110 such that the presence of ammonia
within the fluid is
detected and communicated to the control unit 190. The control unit 190 can be
configurable
to pause and/or power off the first dialysis module 100 upon detection of
ammonia within the
blood flow, or otherwise trigger an alarm. The pH sensors 129 can be, for
example, a
8
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
combination pH sensor, a differential sensor, a laboratory sensor, a process
pH sensor, or
other type of pH sensor.
100361 The dialysate circuit 150 can include a blood detector
152 and connections
158, 160 to the sorbent cartridge 170. The dialysate circuit can include first
portion 162 and
second portion 164. The dialysate circuit 150 is a sterile dialysate circuit
for flow of dialysate
therethrough. The dialysate circuit 150 can allow flow of a dialysate through
the dialyzer 110
and the pump 120, through the sorbent cartridge 170, and back to the dialyzer
110. The
dialysate circuit 150 can, for example, be made of tubing or other conduit
suitable for flow of
dialysate.
100371 The first portion 162 of the dialysate circuit 150 can include a
blood detection
access port connecting the dialysate circuit 150 to the blood detector 152.
The blood
detection access port can be coupled the blood detector 152, such that
presence of blood in
the dialysate exiting the dialyzer 110 can be detected. In some cases,
breakage in the
membranes of the dialyzer 110 can result in blood entering the dialysate flow.
The blood
detector 152 can be in communication with the control unit 190 such that the
control unit 190
will pause and/or power off the first dialysis module 100 upon detection of
blood in the
dialysate, or otherwise cause an. alarm to be initiated to the user.
100381 Dialysate can be driven by the pump 120 from the
dialyzer 110 through
dialysate output 114 into the first portion 162 of the dialysate circuit
towards the sorbent
cartridge 170 via connection 158. In some cases, the first portion 162 of the
dialysate circuit
can be connected to the auxiliary module 180. The dialysate can be driven
through the
sorbent cartridge 170, where the sorbent treats the dialysate, and then the
dialysate flows out
the connection 160 to the second portion 164 of the dialysate circuit. In the
second portion
164 of the dialysate circuit, the dialysate can be driven from the sorbent
cartridge 170 back
towards the dialyzer, where the dialysate can enter the dialyzer 110 through
the dialysate
input 112.
100391 In first dialysis module 100, which is designed to be
mobile, one lighter
weight sorbent cartridge 170 can be used. The sorbent cartridge 170 can be,
for example,
charcoal. Optionally in any example, the sorbent cartridge 170 can be
configured to remove
one or more of organic uremic metabolites and heavy metals. Optionally in any
example, the
sorbent cartridge 170 is configured to remove one or more of creatinine, uric
acid and P2
micro globulins, p-cresol, indoleacetic acid and hippurate. The sorbent
cartridge 170
9
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
comprises activated carbon, such as charcoal. The dialysate exiting the
sorbent cartridge 170
is regenerated dialysate, such that dialysate entering the dialyzer 110 is
cleaned dialysate.
100401 The auxiliary module 180 can be a detachable module for
removal of
ultrafiltrate. In some cases, the first portion 162 of the dialysate circuit
can be connected to
the auxiliary module 180 through the ultrafiltrate outlet port 182. The
ultrafiltrate outlet port
182 can be, for example, a spike for fluid-tight connection and detachment of
the auxiliary
module 180 as desired. The auxiliary module 180 can include ultrafiltrate
outlet port 182, a
pump 184, and an ultrafiltrate collector 185.
100411 The auxiliary module 180 can be removeable or
attachable to the first dialysis
module 100, using a connector element. The connector element can be on the
auxiliary
module 180, and releasably connect with a cooperating connector element on the
first dialysis
system. For example, a surgical spike could also be on the auxiliary module
180, and the first
dialysis module 100 can. have a receptacle such as a resilient rubber seal for
receiving the
spike. In some cases, the connector, such as a surgical spike, can be located
on the first
dialysis module 100 and the cooperating connector is located on the auxiliary
module.
[0042] The ultrafiltrate from the dialysate can exit the
dialysate circuit 150 through
the ultrafiltrate outlet port 182 and can be collected within the
ultrafiltrate collector 185
which can be a bag, cannister or any other reservoir for collecting the
ultrafiltrate. The
ultrafiltrate collector 185 can include an ultrafiltrate inlet port 186
configured to be coupled a
first fluid channel 187. The first fluid channel 187 can be configured to
provide fluid
communication between the ultrafiltrate pump 184 and the ultrafiltrate
collector 185. A
second fluid channel 188 can be coupled to the ultrafiltrate pump 184 to
provide fluid
communication between the ultrafiltrate pump 184 and the dialysate circuit
150. The
ultrafiltrate pump 184 can be used to control flow of ultrafiltrate from the
dialysate circuit
150 into the ultrafiltrate collector 185. The ultrafiltrate pump 184 can be a
micro-pump.
Removal of ultrafiltrate can provide removal of water and sodium from the
dialysate. For
example, the ultrafiltrate removal rate can be maintained at a physiological
rate in order to
reduce or avoid blunt hemodynanriic changes.
[0043] Optionally in any example, the dialysate circuit 150 of
the first dialysis
module 100 can include one or more points at which optional electrolyte is
infusible into the
dialysate flow. One or more types of optional electrolyte solutions can be
added into the
dialysate flow to facilitate maintaining electrolyte homeostasis. For example,
one or more of
optional electrolyte supplement solutions, such as electrolyte supplement
solutions
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
comprising sodium bicarbonate, calcium, and/or magnesium, can be infused into
the dialysate
flow at one or more optional electrolyte infusion points.
100441 Optionally in any example, the second portion 164 of
the dialysate circuit can
include one or more electrolyte infusion ports with electrolyte reservoirs
(not shown). The
electrolyte reservoir can retain an electrolyte solution. Optionally in any
example, the
electrolyte solution can be used to adjust the pi-i of the dialysate. The
electrolyte solution can
be, for examples, sodium bicarbonate solution. The electrolyte solution can be
infused into
the dialysate flow via an electrolyte infusion port. Flow of the electrolyte
solution into the
dialysate flow can controlled by an. electrolyte solution pump. Such an
electrolyte solution
pump can be configured to pump up to about 5 milliliters per hour (mL/hr), or
for example
from about 1 mL/hr to about 2 mL/hr, up to about 5 mL/hr.
100451 The control unit 190 can be in electrical communication
with one or more
components of the first dialysis module 100. For example, the control unit 190
can be in
communication with the bubble detector 141 and the blood detector 152 such
that an alarm is
initiated when air bubbles are detected in the blood flow and/or blood is
detected in the
dialysate flow. Optionally in any example, the control unit 190 is configured
to pause and/or
power down the first dialysis module 100 upon detection of air bubbles in the
blood flow
and/or blood in the dialysate flow. Optionally in any example, the control
unit 190 is
configured to control the pump 120 to provide desired flow of blood and/or
dialysate through
the first dialysis module 100. The control unit 190 can control one or more
optional pumps
configured to control flow of electrolyte into the dialysate, blood thinner
into the blood flow,
and/or ultrafiltrate from the dialysate.
100461 The power source .192 can be a portable power source,
such as a battery or a
rechargeable battery, connected to the first dialysis module 100. In some
cases, the power
source 192 can additionally include an option to plug into a wall outlet.
100471 The user interface 194 can allow for the patient to see
status updates or
monitor functioning of the dialysis first dialysis module 100. The user
interface 194 can
include, for example, buttons, a screen, lights, or other indicia that can
convey whether the
system is functioning properly.
100481 The first dialysis module 100 is lightweight and wearable by a
patient during
the daytime, or when he or she is going about normal daily activities. The
first dialysis
module 100 can be worn, for example, as a belt, shown and discussed with
reference to FIGS
3A-3B, 4A-4C, and 5A-5C below. The light-weight first dialysis module 100 can
include an
11
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
activated carbon cartridge configured to adsorb various toxins from the
dialysate. The
activated carbon is configured to remove one or more of creatinine and j32
micro globulins, p-
cresol, indoleacetic acid, hippurate, and heavy metals, from the dialysate.
Optionally in any
example, the first dialysis module is not configured to remove urea from the
blood flow. hi
the first dialysis module alone, worn in a mobile configuration, a charcoal
sorbent, or other
sorbents known in the art, can continuously removes the free fraction of the P-
BUTS over 24
hours.
100491 The detachable auxiliary module 180 can allow for a
light weight and
comfortable system with flexibility for regular, but not necessarily
continuous, removal of
sodium and water. The patient can strategically and selectively plug into the
auxiliary module
180 as needed to expel fluid. This can be monitored and timed according to the
patient's
needs to avoid hemodynamic problems.
100501 The first dialysis module 100 and the auxiliary module
180 can be combined
with the second dialysis module 200 to allow for removal of additional toxins
over a
.15 shortened, stationary, period of time.
100511 FIG. 2 is a schematic of a stationary nighttime
hernodialysis module 200 for
use with a daytime first dialysis module 100, shown in FIG. 1. The stationary
nighttime
hemodialysis module ("secon.d dialysis module") 200 can include a dialysate
inlet 210,
sorbents 212, 214, 216, ammonia sensor 218, first electrolyte module 220 with
pump 222,
bubble filters 224, 226, flow sensor 228, second electrolyte module 230, and
dialysate outlet
232.
100521 The second dialysis module 200 is a module that plugs
into the first dialysis
module 100 of FIG. 1. The second dialysis module 200 does not perform
heinodialysis alone.
Instead, the dialysate inlet 210 and the dialysate outlet 232 are connected to
the connections
158, 160 of the dialysate circuit 150 of the first dialysis module 100. This
replaces the sorbent
cartridge 170 from the daytime first dialysis module 100 with the sorbent
cartridges 212, 214,
and 216 from the second dialysis module 200. Optionally in any examples, the
sorbent
cartridge 170 from system 100 can be used with the second dialysis module 200
instead of
one of the sorbent cartridges 2.12, 214, 216.
100531 When the second dialysis module 200 is plugged into the first
dialysis module
100 for use by the patient, the dialysate can travel from the dialyzer 110
into the first portion
162 of the dialysate circuit 150, through the blood detector 152, through the
pump 120, up
past the auxiliary module 180, and into the dialysate inlet 210 of the second
dialysis module
12
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
200. Optionally in any examples, the first dialysis module can recharge while
plugged into
the second dialysis module.
100541 The dialysate can then be driven, by the pump 120,
through the second
dialysis module 200, from the dialysate inlet 210 through sorbent cartridges
212, 214, 216 in
sequence. The dialysate can travel through one or more of bubble filters 224,
226, ammonia
sensor 218, and flow sensor 228, in addition to auxiliary electrolyte modules
220, 230, on its
way to the dialysate outlet 232. Once the dialysate reaches the dialysate
outlet 232 of the
second dialysis module 200, it can be driven back into the dialyzer 110.
[0055] The second dialysis module can include a plurality of
types of sorbent
materials configured to regenerate the dialysate. For example, the second
dialysis can include
a plurality of sorbent cartridges to provide a plurality of types of sorbent
materials. A patient
can alternate use of the first dialysis module and a second dialysis module,
for example for
about 1.2 hours each during a 24 hour period, such that the patient remains
mobile during the
day while maintaining overall desired removal of toxins.
[0056] A sorbent material in the one or more sorbent cartridges 212, 214,
216 can
include sorbents such as carbon, charcoal, zirconium phosphate; hydrous
zirconium oxide;
metals or alloys containing zirconium; an organic and/or inorganic compound
comprising
zirconium; minerals comprising zirconium; or urease.
100571 The sorbent cartridges 212, 214, 216, can include a
urea converter cartridge
212 and two other sorbent cartridges 214, 216. The urea converter cartridge
212 can be
configured to convert urea to ammonium carbonate, which in the presence of
hydrogen ions
generates carbon dioxide. For example, the urea converter cartridge can
include urease.
Optionally in any example, the urea converter cartridge 212 comprises one or
more sorbent
materials configured to adsorb toxins in the dialysate. The one or more
sorbent materials can
be configurable to adsorb ammonium, such as the ammonium generated by the
degradation of
urea into ammonium carbonate. Optionally in any example, the one or more
sorbent materials
are configurable to adsorb other cations, including cations of calcium,
magnesium, and/or
potassium.. Optionally in any example, the urea converter cartridge 212
includes zirconium
phosphate. For example, zirconium phosphate in the urea converter cartridge
212 can remove
ammonium from the dialysate, along with calcium, magnesium and potassium
cations, while
releasing sodium and hydrogen ions.
100581 Optionally in any example, the urea converter cartridge
212 comprises more
than one distinct cartridge and/or distinct portions of cartridges. Optionally
in any example,
13
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
the urea converter cartridge 212 is configurable to be split into more than
one distinct
cartridge. The urea converter cartridge 212 can include one or more cartridges
to retain the
urea converter component, such as the urease, and one or more cartridges to
retain the one or
more sorbent materials. For example, the urea converter cartridge 212 can
include a first
cartridge configured to retain the urease and a second cartridge configured to
retain the one or
more sorbent materials. Optionally in any example, the urea converter
cartridge 212
comprises more than one distinct portions, with one or more respective
portions comprising
the urease and one or more sorbent materials.
100591 The first sorbent cartridge 214 can be configurable to
remove one or more
heavy metals and/or one or more anions from the dialysate. For example, the
first sorbent
cartridge 214 can remove one or more of iron, mercury and aluminum. In some
cases, the
first sorbent cartridge 214 is configured to remove one or more phosphate and
sulfide anions.
In some cases, the first sorbent cartridge 214 comprises hydrous zirconium
oxide. For
example, dialysate can flow through the urea converter cartridge 212 and into
the first sorbent
cartridge 214 where heavy metals, such as iron, mercury and aluminum, and
phosphate and
sulfide anions are removed from th.e dialysate, in exchange for acetate.
Zirconium hydroxide
binds phosphate and releases acetate, bicarbonate and sodium in small amounts.
Zirconium
phosphate removes ammonium, calcium, magnesium and potassium.
100601 The second sorbent cartridge 216 can be configurable to
remove one or more
of organic uremic metabolites and heavy metals. In some cases, the second
sorbent cartridge
216 is configured to remove one or more of creatinine, uric acid and 132 micro
globulins, p-
cresol, indoleacetic acid and hippurate. The second sorbent cartridge 216 can
include
activated carbon, such as charcoal. In sonic cases, the second sorbent
cartridge 216 has
characteristics similar to or the same as the sorbent cartridge 170 described
with reference to
FIG. 1.
100611 Once the dialysate flows through the sorbent containing
cartridges 212, 214,
216, the dialysate can be driven back through the second dialysis module 200
past the
ammonia sensor 218, the first electrolyte module 220, the bubble filters 224,
226, the flow
sensor 228, the second auxiliary module 230, and to the dialysate outlet 232,
where the
cleaned dialysate can return to the dialyzer 110. The dialysate exiting the
sorbent cartridges
212, 214, 216 is regenerated dialysate, such that dialysate flowing into the
dialyzer 110 is
cleaned dialysate which can be used to remove toxins from the blood of the
patient. Since the
dialysate system is sterile, ideally, the dialysate would be changed between
each conversion
14
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
from the first dialysis module 100, to the second dialysis module 200, or
between each
conversion from the second dialysis module 200, to the first dialysis module
100.
100621 The second dialysis module 200 can have one or more
ammonia sensors 218
in line with the dialysate circuit. The ammonia sensor 218 can be, for
example, a pH sensor
similar to the pH sensor of first dialysis module 100. The ammonia sensor can
be tied to the
control unit 190 to test for ammonia in the blood circuit. Since ammonia is
such a strong
base, the optional pH sensor provides a safety mechanism to detect when the
sorbent
cartridges are no longer effective for removing ammonia from the system. The
optional pH
sensor is in fluid communication with the blood flow exiting the dialyzer 11.0
such that the
presence of ammonia within the fluid is detected and communicated to the
control unit 190.
The control unit 190 can be configurable to pause and/or power off the first
dialysis module
100 upon detection of ammonia within the blood flow.
100631 Optionally, the second dialysis module 200 can have one
or more bubble
filters 224, 226 in line with the dialysate circuit. The bubble filters 224,
226 can be in fluid
communication with the dialysate such that presence of air bubbles within the
dialysate is
detected and communicated to the control unit 190 control unit 190. The
control unit 190 is
configurable to pause and/or power off the first dialysis module 100 upon
detection of air
bubbles within the dialysate.
100641 The auxiliary electrolyte modules 220, 230 can be in
line with the dialysate
circuit of the second dialysis module 200. The auxiliary electrolyte modules
220, 230, can
provide saline or solution into the dialysate flow. The auxiliary electrolyte
modules 220, 230
can include sodium bicarbonate, and is optional, when the first dialysis
module 100 is primed
with a primer solution containing bicarbonate (HCO3). For example, when the
dialysate
circuit is initially primed with a primer solution, typically containing
saline for half-normal
saline) and bicarbonate (HCO3..), the need for a separate electrolyte
reservoir can be obviated.
100651 The bulkier and heavier second dialysis module 200 can
be configured to
remove urea. For example, the urea converter of the second dialysis module 200
can
decompose urea removed from the blood stream into ammonia and carbon dioxide.
The
second dialysis module can remove the ammonia and vent the carbon dioxide to
release the
gas into the environment. The second dialysis module can include a plurality
of types of
sorbent materials configured to regenerate the dialysate. Due to the heavier
nature of the
second dialysis module, it can be tethered, stationary, and can receive a
power source such as
through a power cord to a wall outlet.
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
[0066] The combined system for hemodialysis including the
mobile first dialysis
module 100 connected to the second dialysis module 200 and the auxiliary
module 180 can
keep the P-BUTS low, at anon-toxic level, during a shortened stationary period
On the other
hand, other substances known to be toxic, such as phosphorus and urea can be
removed from
the blood in sufficient amounts in 6 - 10 hours, thus not requiring longer
periods for a
sufficient removal. Urea and phosphorus are not P-BUTS. These can be removed
using the
bulkier second dialysis module 200.
10067i A patient can alternate use of the first dialysis
module and a second dialysis
module, for example for about 12 hours each during a 24 hour period, such that
the patient
remains mobile during the day while maintaining overall desired removal of
toxins. This can
be done, for example, over a combined cycle for removal of a variety of toxins
between the
first dialysis module and the second dialysis module.
100681 FIGS. 3A-3B are schematic diagrams of a portable
daytime hem odialysis
system 300 with a detachable auxiliary pump module 380 in an example. System
300 can be
similar to, and contain similar components, to first dialysis module 100
discussed with
reference to FIG. 1 above, except where otherwise noted.
100691 System 300 can include an envelope 302, belt 304,
suspenders 306, dialyzer
310, a pump 320, a blood circuit 330, a dialysate circuit 350, a sorbent 370,
and ultrafiltrate
module 380.
100701 The envelope 302 can be an outer layer or skin on the system 300
that
separates the components 310, 320, 330, 350, 370 from the outside environment.
The
envelope 302 can be sized or shaped to cover and conceal these components so
that, to an
outside observer, a patient wearing the system 300, is wearing a bag or box
type item, not a
full dialysis system. The envelope 302 can be waterproof or water resistant so
as to allow the
patient to wear the system 300 in an outside environment in a variety of
weather, or to allow
the patient to wear the system 300 in the shower. The envelope 302 can be
sealed to prevent
influx and outflux of water or components. The envelope 302 can optionally
include a zipper
or other opening mechanism to allow for maintenance of the system 300.
Optionally, the
system 300 can include a user interface on the outside of the envelope.
[0071.] The belt 304 and the suspenders 306 can allow the patient to secure
the system
300 to his or her body. The system 300 can be mounted on the belt 304. The
belt 304 can
allow for the system 300 to be worn on or near the waist or hips of the
patient and adjusted to
the patient waist size. The suspenders 306 can allow for additional security
of the system 300
16
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
on the patient body, such as allowing the patient to situate the system 300 on
their front, side,
or back, as desired. The suspenders 306 can prevent gravity or patient
movement throughout
the day from dislodging the system 300. This can allow patient movement
throughout the
day.
100721 The blood circuit 330 can be containing substantially within the
envelope 302,
with one or more connections 332 protruding out of the envelope, to allow
connection to a
patient circulatory system. For example, the connection 332 exiting the
envelope 302 can
include two connections, one for blood and one for dialysate, connected to a
dual lumen
catheter to allow for a single point for attachment to the patient circulatory
system.
[0073] The dialysate circuit 350, the sorbent 370, the dialyzer 310, and
the pump 320
can all reside within the envelope 302. When the patient desires to use a
connecting
stationary system, such as second dialysis module 200 discussed above, the
patient can open
the envelope, such as by a zipper, and attach the dialysate circuit 350 into
th.e nighttime
system.
[0074] The ultrafiltrate module 380 can be separate from the rest of the
system 300,
such as outside the envelope 302. The ultrafiltrate module 380 can be an
auxilia,' module to
the system 300 and can be easily detachable or connectable to the system 3(X)
when. the
patient desires fluid removal. The ultrafiltrate module 380 can be, for
example, a separate
pouch, bag, envelope, or case, holding an ultrafiltrate collector,
corresponding pump, and
connection for attachment to the envelope 302, such as auxiliary module 180
described with
reference to first dialysis module 100 earlier. The ultrafiltrate module 380
can, for example,
be attached our mounted on the patient's body, such as on his or her leg or
chest, when in use,
and attached through a connection to the envelope 302. If the ultrafiltrate
module 380 is worn
by the patient, the patient can continue his or her normal mobility while
fluid removal is
occurring.
100751 In some cases, the ultrafiltrate module 380 can be
stationary, or on or near a
surface, such as a table, when the patient hooks into the ultrafiltrate module
380. The patient
can know when to use the ultrafiltrate module 380 for removal of fluid such as
by the
patient's change in weight throughout the day, and through careful planning
with his or her
doctor. If the ultrafiltrate module 380 is used while the patient is
stationary, the patient can
then detach from the ultrafiltrate module 380 after fluid removal is done and
resume his or
her normal mobility with just the envelope 302.
17
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
10076] FIGS. 4A-4C are perspective views of a portable daytime
hemodialysis system
400 in an example. System 400 can have components similar to those in first
dialysis module
100 discussed above, except where otherwise noted. System 400 can. include a
casing 402,
belt 404, dialyzer 410, a pump 420, a blood circuit, a dialysate circuit, and
a sorbent 470.
100771 The belt 404 of system 400 can allow for mounting of the components
such as
dialyzer 410, pump 420, blood circuit, dialysate circuit, and sorbent 470,
within the casing
402. In system 400, the components can be mounted in the front of the belt so
that the patient
can wear them on his or her front side as shown in FIG. 4C. This can allow for
the patient to
easily hook the system 400 into his or her bloodstream.
100781 FIGS. 5A-5C are perspective views of a portable daytime hemodialysis
system
500 in an example. System 500 can have components similar to those in first
dialysis module
100 discussed above, except where otherwise noted. System 500 can include a
casing 502,
belt 504, dialyzer 510, a pump 520, a blood circuit, a dialysate circuit, and
a sorbent 570.
100791 The casing 502 on the belt 504 is situated so that the
components are spread
out between a patient's sides or hips. This can allow for wearing of system
500 without a
protrusion at the patient's belly. This can allow for more mobility of the
patient when
bending.
100801 FIG. 6 is a flow chart depicting a method 600 of using
a hemodialysis system
in an example. Method 600 can include steps 610 to 630. Step 610 can include
continuously
removing toxins from blood with a portable dialysis module situated on the
patient's body.
This can be is done, for example, over a first time period during a time when
the patient is
mobile, such as during the daytime. Step 620 can include selectively removing
excess fluid
from the portable dialysis module by connecting the portable dialysis module
to a detachable
auxiliary module comprising an ultrafiltrate collector. This can be done at
particular times
throughout the patient's day.
100811 Step 630 can include removing toxins, including urea,
from the blood with a
stationary dialysis module comprising the portable dialysis module and one or
more sorbents
connectable thereto. Removing toxins, including urea, from the blood with a
stationary
dialysis module can be done over a second time period comprising a time when
the patient is
stationary, such as at nighttime.
[00821 As used herein, and unless otherwise specified, the
term "about" or
!'approximately" means an acceptable error for a particular value as
determined by one of
ordinary skill in the art, which depends in part on how the value is measured
or determined.
18
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
In certain examples, the term "about" or "approximately" means within 1, 2, 3,
or 4 standard
deviations. In certain examples, the term "about" or "approximately" means
within 30%,
25%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, or 0.05%
of a
given value or range. In certain examples, the term "about" or "approximately"
means within
40.0 mm, 30.0 mm, 20.0 mm, 1Ø0mm 5.0 mm 1.0 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6
min,
0.5 mm, 0.4 mm, 0.3 mm, 0.2 aim or 0.1 mm of a given value or range. In
certain examples,
the term "about" or "approximately" means within 1 hour, within 45 minutes,
within 30
minutes, within 25 minutes, within 20 minutes, within 15 minutes, within 10
minutes, within
5 minutes, within 4 minutes, within 3 minutes within 2 minutes, or within I
minute. In certain
examples, the term "about" or "approximately" means within 20.0 degrees, 15.0
degrees, 10.0
degrees, 9.0 degrees, 8.0 degrees, 7.0 degrees, 6.0 degrees, 5.0 degrees, 4.0
degrees, 3.0
degrees, 2.0 degrees, 1.0 degrees, 0.9 degrees, 0.8 degrees, 0.7 degrees, 0.6
degrees, 0.5
degrees, 0.4 degrees, 0.3 degrees, 0.2 degrees, 0.1 degrees, 0.09 degrees.
0.08 degrees, 0.07
degrees, 0.06 degrees, 0.05 degrees, 0.04 degrees, 0.03 degrees, 0.02 degrees
or 0.01 degrees
of a given value or range.
100831 As used herein, the terms "connected", "operationally
connected", "coupled",
"operationally coupled", "operationally linked", "operably connected",
"operably coupled",
"operably linked," and like terms, refer to a relationship (mechanical,
linkage, coupling, etc.)
between elements whereby operation of one element results in a corresponding,
following, or
simultaneous operation or actuation of a second element. It is noted that in
using said terms to
describe inventive examples, specific structures or mechanisms that link or
couple the
elements are typically described. However, unless othenvise specifically
stated, when one of
said terms is used, the term indicates that the actual linkage or coupling may
take a variety of
forms, which in certain instances will be readily apparent to a person of
ordinary skill in the
relevant technology.
(00841 As used herein, the terms "comprises", "comprising", or
any other variation
thereof, are intended to cover a nonexclusive inclusion, such that a process,
method, article,
or apparatus that comprises a list of elements does not include only those
elements but may
include other elements not expressly listed or inherent to such process,
method, article, or
apparatus.
100851 As used herein, the term "mobile," can mean ambulatory,
untethered to a
stationary object, a device with self-contained power, a lightweight device,
and a wearable
19
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
device, a device that can be worn during a typical day without causing
excessive user fatigue
due to weight.
100861 As used herein, the terms "user", "subject" or
"patient" are used
interchangeably. As used herein, the terms "subject" and "subjects" refers to
an animal (e.g.,
birds, reptiles, and mammals), preferably a mammal including a primate (e.g.,
a monkey,
chimpanzee, and a human) and a non-primate (e.g., a camel, donkey, zebra, cow,
pig, horse,
cat, dog, rat, and mouse). In certain examples, the mammal is 0 to 6 months
old, 6 to 12
months old, 1 to 5 years old, 5 to 10 years old, 10 to 15 years old. 15 to 20
years old, 20 to 25
years old, 25 to 30 years old, 30 to 35 years old, 35 to 40 years old. 40 to
45 years old, 45 to
50 years old, 50 to 55 years old, 55 to 60 years old, 60 to 65 years old, 65
to 70 years old, 70
to 75 years old, 75 to 80 years old, 80 to 85 years old, 85 to 90 years old,
90 to 95 years old,
95 to 100 years old, or 100 to 120 years old.
Various Notes & Examples
[0087] Each of these non-limiting examples can stand on its own or can be
combined
in various permutations or combinations with one or more of the other
examples.
100881 Example I can include a system for hemodialysis can
include a first dialysis
module and an auxiliary module detachably connectable to the first dialysis
module. The first
dialysis module can include a dialyzer, a blood circuit configured to receive
blood from a
patient, circulate the blood through the dialyzer, and return cleaned blood to
the patient, a
dialysate circuit configured to circulate dialysate through the dialyzer and
remove impurities
from the blood and a first sorbent for removing toxins from the blood. The
auxiliary module
can include a pump connectable to the dialyzer for pumping the dialysate
through the
dialysate circuit and a filter configured to remove fluid from the system, the
filter fluidly
coupled to the pump and the dialysate circuit.
(00891 Example 2 can include Example 1, wherein the first
dialysis module is
mounted on a belt such that the patient can wear the first dialysis module
during daytime, and
wherein the patient is mobile and untethered.
[0090] Example 3 can include any of Examples 1-2, wherein the
first sorbent
comprises activated carbon for continuously removing the free fraction of
protein bound
urernic toxins.
100911 Example 4 can include any of Examples 1-3, further
comprising a second
dialysis module detachably connectable to the first dialysis module, the
second dialysis
CA 03150740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
module including one or more hook-ups for connecting to the first dialysate
module and a
second sorbent for removing toxins from the blood.
100921 Example 5 can include any of Examples 1-4, wherein the
second sorbent
comprises urease for removing urea from blood.
100931 Example 6 can include any of Examples 1-5, wherein the second
dialysis
module further comprises a power cord for connection to an electrical outlet.
100941 Example 7 can include any of Examples 1-6, wherein the
dialyzer comprises a
side-by-side pulsatile pump fluidly coupled to the blood circuit and the
dialysate circuit, the
pump configured to simultaneously drive blood and dialysate through the
dialyzer.
100951 Example 8 can include any of Examples 1-7, further comprising a flow
sensor
fluidly coupled to one of the dialysate circuit and the blood circuit, the
flow sensor
configured to detect flow of fluid therethrough.
100961 Example 9 can include any of Examples 1-8, further
comprising an envelope
at least partially enclosing the first dialysis module, wherein the envelope
is waterproof
[0097] Example 10 can include any of Examples 1-9, wherein the envelope
comprises
a double layer material.
100981 Example 11 can include any of Examples 1-10, wherein
the envelope further
comprises a zipper configured to allow insertion and removal of the first
dialysis module.
100991 Example 12 can include any of Examples 1-11, wherein
the envelope further
comprises a connector element for connecting the auxiliary module to the first
dialysis
module.
[00100] Example 13 can include any of Examples 1-12, wherein
the auxiliary module
further includes a pump connectable to the dialyzer for pumping the dialysate
through the
dialysate circuit; and a filter configured to remove fluid from the system,
the filter fluidly
coupled to the pump and the dialysate circuit.
1001011 Example 14 can include any of Examples 1-13, further
comprising an inlet for
a dual lumen catheter for fluid connection to the dialyzer.
1001021 Example 15 can include any of Examples 1-14, wherein
the first dialysis
module further comprises a battery.
[001.03] Example 16 can include any of Examples 1-15, wherein the first
dialysis
module and the second dialysis module are configured to be used in an
alternating fashion
over a combined cycle to provide hemodialysis to a patient.
21
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
[00104] Example 17 can include a method of hemodialysis
including continuously
removing toxins from blood with a portable dialysis module situated on the
patient's body
and selectively removing excess fluid from. the portable dialysis module by
connecting the
portable dialysis module to a detachable auxiliary module comprising an
ultrafiltrate
collector.
1001051 Example 18 can include Example 17, wherein continuously
removing toxins
from blood with a portable dialysis module is performed over a first time
period comprising a
time when the patient is mobile.
1001061 Example 19 can include any of Examples 17-18, further
comprising removing
toxins, including urea, from the blood with a stationary dialysis module
comprising the
portable dialysis module and one or more sorbents connectable thereto.
1001071 Example 20 can include any of Examples 17-19, wherein
removing toxins,
including urea, from the blood with a stationary dialysis module is performed
over a second
time period comprising a time when the patient is stationary.
[00108] Each of these non-limiting examples can stand on its own, or can be
combined
in various permutations or combinations with one or more of the other
examples.
1001091 The above detailed description includes references to
the accompanying
drawings, which form a part of the detailed description. The drawings show, by
way of
illustration, specific examples in which the invention can be practiced. These
examples are
also referred to herein as "examples." Such examples can include elements in
addition to
those shown or described. However, the present inventors also contemplate
examples in
which only those elements shown or described are provided. Moreover, the
present inventors
also contemplate examples using any combination or permutation of those
elements shown or
described (or one or more aspects thereof), either with respect to a
particular example (or one
or more aspects thereof), or with respect to other examples (or one or more
aspects thereof)
shown or described herein.
1001101 In the event or inconsistent usages between this
document and any documents
so incorporated by reference, the usage in this document controls.
[00111] In this document, the terms "a" or "an" are used, as is
common in patent
documents, to include one or more than one, independent of any other instances
or usages of
"at least one" or "one or more." In this document, the term "or" is used to
refer to a
nonexclusive or, such that "A or B" includes "A but not B," "B but not A," and
"A and B,"
unless otherwise indicated. In this document, the terms "including" and "in
which" are used
22
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
as the plain-English equivalents of the respective terms "comprising" and
"wherein." Also,
in the following claims, the terms "including" and "comprising" are open-
ended, that is, a
System, device, article, composition, formulation, or process that includes
elements in
addition to those listed after such a term in a claim are still deemed to fall
within the scope of
that claim. Moreover, in the following claims, the terms "first," "second,"
and "third," etc.
are used merely as labels, and are not intended to impose numerical
requirements on their
objects.
100112] Method examples described herein can be machine or
computer-implemented
at least in part. Some examples can include a computer-readable medium or
machine-
readable medium encoded with instructions operable to configure an electronic
device to
perform methods as described in the above examples. An implementation of such
methods
can include code, such as microcode, assembly language code, a higher-level
language code,
or the like. Such code can include computer readable instructions for
performing various
methods. The code may form portions of computer program products. Further, in
an
example, the code can be tangibly stored on one or more volatile, non-
transitory, or non-
volatile tangible computer-readable media, such as during execution or at
other times.
Examples of these tangible computer-readable media can include, but are not
limited to, hard
disks, removable magnetic disks, removable optical disks (e.g., compact disks
and digital
video disks), magnetic cassettes, memory cards or sticks, random access
memories (RAMs),
read only memories (ROMs), and the like.
[00113] The above description is intended to be illustrative,
and not restrictive. For
example, the above-described examples (or one or more aspects thereof) may be
used in
combination with each other. Other examples can be used, such as by one of
ordinary skill in
the art upon reviewing the above description. The Abstract is provided to
comply with 37
C.F.R. 1.72(b), to allow the reader to quickly ascertain the nature of the
technical disclosure.
It is submitted with the understanding that it will not be used to interpret
or limit the scope or
meaning of the claims. Also, in the above Detailed Description, various
features may be
grouped together to streamline the disclosure. This should not be interpreted
as intending
that an unclaimed disclosed feature is essential to any claim. Rather,
inventive subject matter
may lie in less than all features of a particular disclosed example. Thus, the
following claims
are hereby incorporated into the Detailed Description as examples or examples,
with each
claim standing on its own as a separate example, and it is contemplated that
such examples
can be combined with each other in various combinations or permutations. The
scope of the
23
CA 03180740 2022- 11-29
WO 2021/243200
PCT/US2021/034844
invention should be determined with reference to the appended claims, along
with the fUll
scope of equivalents to which such claims are entitled.
24
CA 03180740 2022- 11- 29
